Prostate Cancer Survivors MOving Toward Exercise (PROMOTE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 423
- 试验地点
- 2
- 主要终点
- Change in Physical activity Levels From Baseline to Month 1 and Month 3
研究概览
简要总结
The primary purpose of the study is to determine the effects of an implementation intention intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary aims are to (a) compare the effects of a telephone-assisted implementation intention intervention against a self-administered implementation intention intervention and a standard recommendation group on physical activity behaviour and (b) document the effects of these interventions on quality of life (QoL), fatigue, symptom management, and physical functioning.
Hypotheses: Evidence exists that an implementation intention intervention can lead to significant improvements in PA levels and that regular PA has been shown to improve QoL, fatigue levels, manage symptoms and improve physical functioning in cancer survivors'. As such, the following hypotheses were generated: (1) prostate cancer survivors exposed to the researcher-assisted implementation intention intervention will have higher PA levels at the 1- and 3-month follow-ups compared to the self-completed implementation intention intervention and the standard recommendation group; (2) prostate cancer survivors in the researcher-assisted implementation intention intervention will show significant improvements in QoL, fatigue levels, symptom management, and physical functioning compared to the self-completed implementation intention intervention and the standard recommendation group at the 1- and 3-month follow-up; and (3) prostate cancer survivors in the self-completed implementation intention intervention will have higher PA levels, and better improvements in QoL, fatigue levels, symptom management, and physical functioning compared to the standard recommendation group at the 1- and 3-month follow-ups.
详细描述
BACKGROUND:
Prostate cancer remains the most frequently diagnosed cancer among Canadian men, with an estimated 24,600 men being diagnosed in 2010. In Alberta specifically, roughly 2,500 men will be diagnosed with prostate cancer, and 440 men will die of the disease in 2010 (Canadian Cancer Society, 2011). Improvements in the treatment of prostate cancer has reduced tumour growth and improved survival rates, however, it has also been associated with significant negative changes in cancer survivors' quality of life, physical functioning, body fat percentage and fatigue levels that may persist for years following treatment. One behavioural strategy that has been consistently shown to combat these negative side effects and enhance psychosocial and physical well-being in prostate cancer survivors is physical activity. Unfortunately it has been established that physical activity levels decline significantly from pre-diagnosis to during treatment and may never regain pre-diagnosis levels; thus it is important to test novel, innovative and inexpensive ways to increase physical activity patterns in prostate cancer survivors.
PURPOSE:
The primary purpose of the study is to determine the effects of an implementation intention intervention on physical activity behaviour in prostate cancer survivors. Secondary aims are to (a) compare the effects of a telephone-assisted implementation intention intervention against a self-administered implementation intention intervention and a standard recommendation group on physical activity behaviour and (b) document the effects of these interventions on quality of life, fatigue, symptom management, and physical functioning.
METHODS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Prostate cancer survivors
- •at least 18 years old
- •proficient in English
排除标准
- 未提供
研究组 & 干预措施
Standard PA Recommendation
Received the standard physical activity recommendation.
Telephone Implementation Intention
Behavioural Telephone Assisted Implementation Intention Intervention
干预措施: Telephone Implementation Intention (Behavioral)
Self-completed implementation intention
Self-administered implementation intention intervention.
干预措施: Self-completed implementation intention (Behavioral)
结局指标
主要结局
Change in Physical activity Levels From Baseline to Month 1 and Month 3
时间窗: baseline, 1 month, 3 months
Measured by the Leisure score index. Looking for change in Physical Activity levels from baseline to month 1 and month 3 follow-ups.
次要结局
- fatigue(baseline, 3 months)
- Quality of life/ physical functioning(baseline, 3 months)
研究者
Kerry Courneya
Professor
University of Alberta